Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission
- Conditions
- Rheumatoid Arthritis in Remission
- Interventions
- Other: Articular ultrasound
- Registration Number
- NCT02618954
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA).
At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years.
However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care.
The investigator propose to conduct a prospective, bi-center, non randomized study.
- Detailed Description
The study population will include all RA patient at least 18 years old in clinical remission for less than 6 month.
The primary endpoint (ability of US-detected residual synovitis to predict relapse or radiographic progression in individual patients and joints) will be evaluated afer 12 months of follow-up The total follow-up will be 12 months with a follow-up every 3 months. In addition to the standard care, each follow-up will include an ultrasound examination of 40 joints and 8 tendons
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- Age ≥ 18 years
- PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria
- Patient treated by DMARDs (disease-modifying antirheumatic drug)
- Patient in confirmed remission for less than 6 months
- Patient participating simultaneously in another clinical study with blind treatment
- Patient participating simultaneously in another clinical study involving decreasing of drug dose
- Patient in post clinical study exclusion period
- patients subject to legal protection measures
- Patient unable to read French
- Pregnant or breast-feeding women
- patient treated with Rituximab
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study patient Articular ultrasound Articular ultrasound at each study follow-up
- Primary Outcome Measures
Name Time Method 1 year pejorative evolution 1 year after inclusion Number of patient with a clinical relapse
- Secondary Outcome Measures
Name Time Method Structural progression 1 year after inclusion Number of patient with a structural progression of the illness
RA (Rheumatoid Arthritis) remission duration At each follow-up (3,6,9 and 12 months after inclusion) Evaluation of the remission duration (patient in both clinical and ultrasound remission)
RA ultrasound remission duration At each follow-up (3,6,9 and 12 months after inclusion) Evaluation of the ultrasound remission duration
RA clinical remission duration At each follow-up (3,6,9 and 12 months after inclusion) Evaluation of the clinical remission duration
Clinical relapse at one year 1 year after inclusion Evaluation of the probability of a clinical relapse at 1 year based on the ultrasound data
Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments) At baseline identifying initial factors that can explain persistence of ultrasound synovitis despite clinical remission
Radiographic progression at 1 year 1 year after inclusion Evaluation at joint level the probability of a radiographic progression in presence of a non active synovitis
Intra-observator reproductibility 1 year after inclusion Evaluating the intra-observer reliability for US synovitis through study completion
Trial Locations
- Locations (1)
Montpellier University Hospital
🇫🇷Montpellier, Herault, France